Testing of pharmacopoeial ethanol (disinfectant ethanol)
Ethanol has antimicrobial properties and is sold as a disinfectant product at optimized concentrations. Quality control of alcohol as a medical product is carried out through verification testing methods stipulated by various pharmacopoeias. As part of an agreement, the procedures for verification testing of ethanol or anhydrous ethanol in disinfectants are roughly the same in the Japanese (JP), United States (USP) and European (EP) pharmacopoeias.
Verification test – component identification via the infra-red absorption spectrum
In the verification testing of ethanol and anhydrous ethanol, identification of components is carried out using Fourier transform infra-red spectrophotometer(FT-IR). Reference spectra are compared with the spectra of the target compounds. The Japanese Pharmacopeia (JP) specifies a liquid membrane technique test, and below is a measurement example of ethanol and anhydrous ethanol using a liquid cell (KRS-5 window disk).
Purity test – analysis of volatile impurities
Volatile impurities in ethanol are detected with a gas chromatograph (GC). Methanol, acetaldehyde, acetal, benzene, etc. are checked as impurities. An appropriate instrument configuration is required to detect the specified 2 vol ppm limit of trace benzene and obtain good separation for acetaldehyde and methanol (separation of 1.5 or higher). The testing of disinfectant ethanol is covered under the general protocol for purity testing of ethanol.
Example analysis of volatile impurities in ethanol
UV absorbance test – impurity analysis
The absorbance spectrum of an ethanol sample is used to test for the presence of impurities. A UV-Vis spectrophotometer is used at a wavelength range of 235-340 nm with water as a reference sample. The absorbance at three points (240 nm, 250-260 nm, 270-340nm) is checked as being below certain tolerance values (0.40, 0.30, and 0.10 respectively).
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